EU Solidarity and Policy in Fighting Infectious Diseases: State of Play, Obstacles, Citizen Preferences and Ways Forward

In this paper we confront the role the EU traditionally plays in the domain of health with the urgent need for collective action triggered by the corona virus pandemic. In the face of such a crisis, we argue that the joint procurement, stockpiling and allocation of medical countermeasures is a key component of true European solidarity, besides maintaining the integrity of the Single Market. We present the first results of a survey experiment taken before the current crisis on citizens’ attitudes towards centralizing at the EU level of policies to combat infectious diseases, which indicates considerable support. We conclude that a more robust policy framework with substantial centralization of procurement, stockpiling and allocation is warranted.


Introduction
Since a few weeks the world has been in the throes of the outbreak of COVID-19. At the moment of writing, there have been over 950,000 confirmed cases and almost 50,000 deaths worldwide. Healthcare systems are completely overburdened, while the economic implications are devastating. Vaccines are the number one counter measure to stop this and future pandemic outbreaks and save human life. And yet, the development and dissemination of just such vaccines and medical countermeasures generally are where the political fights can be fiercest. The US government tried to secure rights and access to EU-based vaccine developers through its legal, political and financial power -flouting global solidarity regarding access to counter measures against the COVID-19 outbreak. Among other moves, it has reportedly sought to buy one of the companies based in Germany that has been building a vaccine dossier expected to be centrally authorized in June or July of this year. Apparently, Germany has prevented the completion of this sale and its government is now working with the EU to come up with a more general strategy and solution to address this kind of challenge, and to promote more solidarity in the pooling of resources and risk. This incident might not be the last attempt, by the US or any other country or party, to go it alone and thus disregard the need for global solidarity. In a broader sense, organizing societal solidarity is also a counter-measure against the wider implications of a serious disease outbreak, for instance in economic terms. However, this paper focuses on narrower aspect of solidarity: within the domain of healthcare, what are the best policy options for organizing EU solidarity with regard to medicinal counter-measures to infectious diseases?
This paper addresses this question on the backdrop of a legal and economic policy analysis, informed research on public attitudes. We first discuss what 'EU health solidarity' means. Solidarity is a well-known organizing principle in national health care systems, guiding the distribution and rationalization of the public goods involved in this domain. This principle is also recognized in the EU's legal constellation, although there has always been a tension between this domestic solidarity principle and the EU's internal market principles. Second, we outline the manner in which the EU promises to organize collective action based on true European solidarity to address pandemics. This promise could have come from the Treaty changes with the Lisbon amendments and new regulation adopted after the 2009 Swine Flu outbreak; nevertheless, the EU's competences in health remain relatively limited, and even after the Swine Flu the way forward proved to be difficult, given significant hesitations in Member States. Third, we empirically report results from a survey experiment among a representative sample of 400 Dutch citizens (yielding 2400 judged policy packages) surveyed before the outbreak of the current crisis. The experiment explores what the EU role should be with respect to organizing solidarity regarding access to pandemic medicines.
The conclusions emerging from these three steps are clear: there are good social, economic and legal arguments, and likely also meaningful public support for procuring, stockpiling and allocating medical counter measures to  other infectious diseases at the EU level. This eliminates the inefficiency associated with excess demand and excess supply co-existing in various parts of the EU. More importantly, it allows massive firepower to be instantly targeted to wherever an outbreak starts. And if well-organized ex ante, it secures credible commitments by all Member States to the cooperation that is needed ex post, when a crisis hits.

Solidarity in public health and health care
Health policy and law pertains to that area of our life where we face shared risks and opportunities related to life, disease and mortality. 2 Solidarity in health is generally linked to a sense of commitment to help those in need, even if we do not know exactly whom we are helping. The donation of blood in this regard is often cited as how -in the context of shared risks and human suffering -solidarity is a driving force for societal organization. 3 Particularly when there is an emergency, people are keen to help out and solidarity is widely seen as more acceptable than self-help. 4 Solidarity in health is multifaceted. In bioethics, solidarity has a long history; 5 it has been used particularly in the context of public health (as opposed to health care/medical care) to justify state interferences such as quarantines or mandatory medical examinations and vaccinations, i.e. the enforcement by public authorities of necessary collective action, which can be understood as a demand of solidarity. 6 When it comes to resource allocation for access to medical care and medicines, solidarity also forms a key principle and value: here, it justifies mechanisms of insurance, redistribution, planning and rationing, to ensure access to medicines and services that are needed to promote and protect human health as part of the welfare system. 7 The implementation of this notion of solidarity in the organization of public health and health care systems is key to ensure equal access to medical and preventive care, as well as 'universal access',in all EU Member States. 8 Universal access means that each citizen is granted equal access to a specific basket of care and medicines. Solidarity in ensuring universal access to health care and medicines always entails rationing access. In most Member States this means that 3 'Implicit solidarity': Catherine Waldby and Robert Mitchell, The Union is founded on the values of respect for human dignity, freedom, democracy, equality, the rule of law and respect for human rights, including the rights of persons belonging to minorities. These values are common to the Member States in a society in which pluralism, non-discrimination, tolerance, justice, solidarity and equality between women and men prevail.  Simultaneously, there has always been a tension between the domestic principles of solidarity and the principles of market integration that underpin the Single Market.
In the application of the internal market rules, any national health laws that created a barrier to the free movement of goods or services were suspect and needed to be justified as a valid exception to the free movement principle. In fact, some of the Drawing and re-drawing the thin line between 'national solidarity' and 'national public health' demand, on one hand, and the principles of market integration and free movement, on the other hand, has been the subject of much of the Court of Justice of the European Union (CJEU)'s activity and case law. It is no surprise that, from the perspective of the national health care authorities, the EU's most salient role was often seen as hinging upon policies of deregulation.
At the same time, as the Tobacco Advertising case indicates, the removal of national health laws as barriers to the single market is not the only aspect to the role of the EU in health. The tobacco advertising regulation was a central part of the EU's cancer prevention programme that is built on regulation of advertising, the modalities of tobacco sale and research and public health programmes into cancer prevention. 22 Similarly the EU has had a central role for the regulation of health and safety of the EU products market, medical devices, pharmaceuticals, the recognition and quality of medical professionals and workplace safety. 23  Overall, the difficulty in separating health and the internal market is clearly apparent, but the division remains and is reiterated with each Treaty amendment. In fact, although health is mentioned throughout the Treaty as an exception to the free market principles and as a general EU goal, Article 168 TFEU, which outlines the EU's role and responsibility in health, simultaneously reinforces the premise that the EU does not have the power to create health law outside of specifically outlined situations. 25 EU scrutiny of national public health laws is highly developed in EU case law, particularly as it comes to the free movement of goods. This is a relevant legal backdrop for the organization of solidarity via the public procurement of vaccines at EU level that followed after the Swine Flu outbreak, which we discuss in the next section.

Limited EU competences in health, even after Swine Flu
In order to understand the current role the EU can have with respect to organizing solidarity for responding to COVID-19, particularly with regard to the public procurement of pandemic medicines and medical counter measures more generally, And that experience has led to at least some of the elements in the EU policy landscape within which we now find ourselves.
In With respect to EU regulation, at the time of the 2009 Swine Flu outbreak, no secondary legislation had been adopted on the basis of this added paragraph in Article 168 TFEU. However, a major problem arose with respect to the availably of pandemic vaccines and antivirals. The Commission had been trying for years to create a stockpile of antivirals. Nevertheless, this was deemed unacceptable by the Member States that wanted to keep the ability to procure medication at Member State level: Although the approval process of medicines is highly integrated at the EU level, the actual procurement of medicines is still a firm competence of the Member States. The procurement is the most costly aspect of ensuring access to pandemic medicines, given that the average cost is between 5 and 10 euros per dose per person. 30 Lack of transparency adds to these problems; often it is simply not possible to access information on development and acquisition costs, as this is part of the procurement contracts between industry and the EU Member States. 31 After the outbreaks of Bird Flu (avian influenza) and SARS, the Member States had made pre-purchase agreements with the pharmaceutical industry. This meant in many cases that as soon as the WHO declared a public health emergency of international concern, these pre-purchase agreements were activated and Member States had to accept the volume and price that was initially agreed. 32 In some cases this meant that vaccines and antivirals did not go to the countries in the EU that needed them most, and the price was often above-and-beyond reasonable. 33  get access, and a stockpile was created where Member States that had too many vaccines that could be offloaded. 34 As one EU civil servant summarized the situation in 2010: We discussed the EU stockpile of antivirals until we were all exhausted and then decided that there was no agreement. And when the pandemic happened, they [MS] suddenly found themselves in the situation that some countries had far too much and some countries had none. And there was no way to deal with this in the middle of the crisis so we needed to (…)  Another route for a more central role for the EU could be under the heading of EU solidarity proper, rather than in the context of the EU health law regime. Article 222 TFEU mandates that in disasters Member States provide mutual assistance and act in cooperation. However, such cooperation is voluntary. 54 The EU Civil Protection Mechanism established on the basis of Article 222 TFEU, depends on the willingness of Member States to join forces. In 2019 the Civil Protection Mechanism was strengthened by 'rescEU', in an attempt to centralize EU capacities. 55 Article 12 of this Decision provides for the EU to use its internal funds, pre-committed national funds and EU co-financed Member States capacities at the disposal of EU efforts, to respond to a major emergency.
Importantly, this mechanism also creates the possibility for joint procurement, operating in parallel to the Joint Procurement Agreement under the health infrastructure. 56 Here the Commission can assume a more central role, because the Decision allows for central EU implementing decisions towards distribution and allocation. Nevertheless, the actual capacity of "rescEU" still largely depends on Member States' willingness to contribute, and it is doubtful that for medical countermeasures EU internal funding will be comparable to what can be organized at the national level or through the JPA in the EU health context. All these are steps forward, but, simultaneously, one needs to be mindful of the very diverse realities of medicinal purchasing powers in the Member States, the absence of a EU budget in this regard and the highly intergovernmental nature of the process, which is inevitably very bureaucratic, difficult to manage and not generating the speed that an urgent procurement process would need. Furthermore, in a context such as the COVID-19 pandemic, difficult and delicate decisions will have to be taken Commission, rather than the current structure where all contracting parties have to instantly agree on the deployment of medical counter measures in accordance to urgency and need, and rules that are sufficiently clear ex ante, with strong measures against any free-riding.

EU role for health solidarity: export limitation of medicines and other crucial goods
When it comes to medicines as one of the counter measures of central importance in combating COVID-19, in the Commission Communication that was published recently, 57 the free movement of goods is mentioned as one of the instruments for coordinating Member States' actions. Particularly, the Communication addresses the situation in which certain medical equipment and goods are scarce and need to be 'channeled to those who need them most'. 58 Thus, free movement and the integrity of the Single Market are now seen as necessary vehicles for true European solidarity. As a rule within internal market law, whenever a Member State creates a barrier to the free movements, this needs to be communicated, so all other Member States can be informed. 59 In the case of goods that are deemed essential for fighting COVID-19 the Commission has established a task force to ensure that these comments are mediated. One of the limitations to the use of the public health exception is already that these national restrictions cannot exist in rules that prevent national firms from responding to public procurement that is tendered at EU level. 60 As some Member States have started hoarding certain products or limiting their suppliers' access to the European market, these measures can also interfere with the public health goal at the EU level of getting these supplies to those who need them most. This means that the Commission sees stockpiling or interrupting supply chains of vital importance to the whole of the EU as potentially prohibited export Member States for a solid public health reason want to restrict export, they have the authority to do so as long as it is done in a proportionate and non-discriminatory fashion. The principle of proportionality however that is outlined by the Commission is of a different nature: [The measures need to be] appropriate, necessary and proportionate to achieve such [health] objective, by ensuring an adequate supply to the persons who need the most while preventing any occurrence or aggravation of shortages of goods, considered as essential -such as individual protective equipment, medical devices or medicinal products -throughout the EU.
Particularly this last iteration is a novel addition that is not based on case law or any other legal instrument. It assumes a concept of EU public health and EU solidarity, rather than the usual interpretation where public health is a policy area in whicheven in the face of the strong economic and integrative forces of the internal market of the EU -domestic solidarity within Member States (and Member States' sovereignty in this domain) is the principle that has to be traded-off against market integration.
According to the European Commission, this means an outright export ban will not be deemed proportionate; the measure needs to be aimed and ensuring that the products reach the persons who need them most, and it needs to suit the objective of the health of people who need them most. Clearly this is not the usual interpretation of Article 35 TFEU juncto Article 36 TFEU, which was never intended to only serve public health at EU level. Rather, it was there for the creation of the internal market, despite national health laws. However, other measures that may create barriers to free movements, such as price regulation in Member States, as long as these are not discriminatory, are allowed according to the Commission. So too are other national measures to regulate the market of medical supplies. Importantly, the EU procurement of a pandemic medicine and other medical products can be severely undermined if Member States, in the face of COVID-19, disrupt supply chains. The process within the JPA is intergovernmental, and runs the risk of playing out in the context of actual export bans. Beyond the case of an EUwide procurement arrangement, solidarity is also undermined by hoarding and limitations in the supply chain, let alone by the economic impact of such measures.

However, even if the Commission would adopt a 'EU health solidarity -based'
interpretation for scrutinizing whether national export bans fall under the public health exception to the free movement of goods, the question is whether at the current moment, the possibility of an infringement procedure from the European Commission would scare Member State politicians more than not having control over the stockpiles of particular goods.
One manner in which the Commission's proposal in the Communication is creating more political pressure in this regard is through the taskforce that involves the Member States for looking into national export limitations. Member States' markets are highly integrated, hence in this intergovernmental taskforce the Commission might be able to leverage political power more than a mere infringement procedure might be able to do. At the same time, this situation also clearly calls for a pandemic budget and power at the EU level to ensure the distribution of medicines and urgently needed medicines for the whole of the Union.

What would citizens want from EU health solidarity in the procurement of pandemic medicines?
In exploring the role the EU could have for ensuring health solidarity when it comes to a pandemic emergency and the availability of countermeasures, it is also important to consider citizens' preferences. This is difficult, however, given the paucity of wellformulated survey questions and research designs -not least given the unfamiliarity among citizens with medical risk-pooling, and also the given the tendency of people to express opinions about health matters in socially desirable ways rather than expressing true thinking.
To shed at least some light on public support for the EU's role in medical procurement, we conducted an original experiment as pilot to a larger survey project on attitudes towards EU fiscal and medical policies. The pilot was administered in access based on prioritizing countries to prevent spread); and (3) Do respondents prefer a programme that is administered by EU-level experts or instead national-level experts? (Possible answers: a. national-level experts; b. EU-level experts). In the conjoint experiment, respondents do not issue a judgment about the individual dimensions. Instead they are asked to judge entire packages exhibiting a given combination of policy features of those dimensions. In particular, respondents choose among and rate randomly assigned alternative packages that combine a random combination of policy features (from each of the three policy dimensions one answer from the set of possible answers to that dimension). This experimental approach evokes more honest answers from respondents even with respect to socially undesirable answers.
What this experimental study has revealed is preliminary evidence, being based on a limited sample in a given country and a particular period of time just prior to the corona virus outbreak. But what it reveals about public support for EU medical procurement is important. We shall focus on two basic patterns in the answers that Dutch respondents gave. First, there is a plurality of support for as opposed to opposition to such EU pharmaceutical sharing. This is clear in Figure 1 below, where the combination of somewhat and strongly support given to any given package garners almost 44 per cent of the Dutch sample, while 'only' 23 percent is opposed (32 percent is indifferent). These patterns are not significantly different across basic demographic sub-groups (younger versus older respondents; more or less educated respondents; men versus women). This is a sign, however tentative, that EU-level procurement would command substantial support among the Dutch population. to choose an EU-procurement policy package that has this particular feature. dimension on 'WHO ADMINISTERS?', respondents are very weakly less likely to prefer national-level administration than EU-level administration (the baseline), but this is clearly not a statistically meaningful difference (note that a substantial part of the confidence interval crosses the vertical line). On the other hand, Figure 2 shows that the Dutch respondents clearly do tend to prefer an EU programme that covers a broader swath of medicines, potentially all medicines: focusing on the first dimension 'FOR WHICH MEDICINES?' we see that respondents are about 15% more likely to choose an EU procurement policy that includes such coverage over a policy that focuses only on a narrow set of medicines (the baseline). Finally, Figure 2 also shows that the respondents are even more likely to prefer an EU procurement policy that gives priority access to particular countries to prevent contagion: focusing on the second dimension 'PRIORITY ACCESS', we see that respondents are about 23% more likely to choose EU-procurement policy that gives priority access to countries where a contagion can be traced, to simply providing access to medicines based on a country's actual contributions, without looking at such a priority in need (the baseline).
Obviously, because the survey was only conducted among a limited number of respondents from one country at one specific moment, one should not overinterpret the outcomes. It is also well-known that the framing of a survey experiment can have a substantial effect on the outcomes. Moreover, the current experiment took place at a moment when the described frame was still hypothetical and before any public debate about centralization of policies in response to infectious diseases has taken place. In the midst of the current corona virus crisis respondents' answers would likely be shaped by the crisis experience so far. Given that the shortcomings of the current decentralized policies have become so obvious, it is not at all clear that support for more centralized policies will have fallen. Hence, we interpret our pilot experiment's results as providing qualified but significant support for the view that there is meaningful political traction for EU-level pooling of procurement capacity in the Dutch sample.

Policy suggestions for an effective way forward
For a long time, the organization of solidarity or health concerns were seen as potential arguments to set limits on the Single Market principles that guide European integration, and even to organize a degree of 'protectionism' -against the thrust of and 'national health' demands, on one hand, and the principles of market integration and free movement, on the other hand, has been the subject of much CJEU activity and case law. We have now entered into a debate that is, in a sense, opposite: now, medical counter-measures as is outlined in "rescEU", without the inefficiencies that are currently there as a result of the current intergovernmental and voluntary nature of the process under the health regime and the legally embedded possibilities for unsolidary behavior. 63 Central procurement is needed for protective devices, and will certainly be needed for the vaccine against the COVID-19 virus as soon as it becomes available. It will also be needed for future infectious diseases. Funding of the capacity can come from the EU budget or by levying a separate contribution from the Member States, say in proportion to their GDP, their population and their demography. The demography is relevant, because countries with an elderly population will on average need to make more use of medicines. It cannot be excluded that the proposed centralization of policies has elements of redistribution, for example when contributions are linked to GDP. However, there relative limited redistributive effects should be weighed against the benefits of the centralization.
What are these benefits? First, an advantage of centralizing procurement is that it will be more difficult for pharmaceutical companies to play off Member States against each other by threatening not to supply to an individual Member State if it tries to negotiate lower prices.
Secondly, the advantage of having a common stockpile of medical counter-measures managed at the EU level is that excess demand in some countries and excess supply in other countries, an obvious economic inefficiency, can no longer co-exist. Thirdly, and most importantly, because the stockpile is common and, hence, larger than any potential national stockpile, there is much greater firepower to target outbreaks of infectious diseases wherever and as soon they emerge. In other words, risk sharing against the consequences of pandemics becomes much more effective than when each country is responsible for its own stock of medicines and equipment.
Finally, the decision where to target the firepower should be taken at the central level.
This avoids that each country tries to deviate from the cooperative solution by securing as much of the medicine supply as possible at the cost of other countries. 63 Costa-Font, J. (2020), Europe's failure to address Covid-19 shows the need for a European 'health citizenship', argues in favour of a European 'health citizenship', https://www.socialeurope.eu/europesfailure-to-address-covid-19-shows-the-need-for-a-european-health-citizenship . His arguments are mainly based on the fact that European governments adopt widely differing policy responses to the Covid-19 crisis, which is hard to motivate as an optimal solution.
Breaking away from the cooperative solution would likely be self-defeating, because it reduces the chances to quell a disease outbreak where it starts. However, political decision makers may not be able to see this or may be under political pressure to secure the safety of their own population first.
In other words, once a disease outbreak has started, cooperative agreements are not credible. 64 Ideally, the EU sets up arrangements ex ante that are ex post credible.
Obviously, Europe has missed the 'ex ante' of this crisis. However, a crisis may also be a moment to get to solutions that are unthinkable in normal times 'Crises which hit the consumer are excellent ways of speeding up policies.' 65 . We have seen that during the European debt crisis when crisis arrangements like the ESM were set up.
Our proposal of the centralization of procurement, stockpiling and deployment decisions of medical countermeasures to infectious diseases is ex-post credible, provided the design is right. This requires centrally-controlled guidance on the use of medicines based on the pooled expertise and instructions of the European Medicines Agency and the European Centre for Disease Prevention and Control. Such guidance will be easier when it is laid down in advance, before an infectious disease emerges.
New diseases will obviously have unknown features. However, the optimal response to an infectious disease in its very first stages is likely to always be very similar, namely the concentration of substantial resources targeted at the first victims and containment within direct environment. The optimal response to a crisis that is already in full swing, like the current one, is more difficult to define. In particular, once a vaccine for Covid-19 becomes available, it would be to the experts to determine the best allocation of the vaccines given the availability and the objective, for example the minimization of lost years of life or number of casualties. Ethical considerations will inevitably play an important role for in determining the relevant objective. However, these are the domain of the politicians rather than the experts.
Risk-sharing arrangements dealing with disease outbreaks can even be taken a step further. It is obvious that the cost of drastic measures like a lockdown of a local economy are mostly borne at the level of that economy, while the benefits in terms of containing a disease are enjoyed by the entire EU. The uneven cost-benefit trade-off 64 A cooperative agreement in this context is to be understood as an agreement among decentralized decision makers, which is to be distinguished from the case of a single decision maker at the EU level. 65 Ruijter (n 7) 114. at the local or national level may make the authorities at those levels reluctant to take drastic measures. Having a central capacity that can compensate for the financial consequences of such measures will help to equalize the return" to such measures to their broader EU return.
No doubt there will be hesitations and obstacles in place -despite the lessons learned from the Swine Flu epidemic and the tragic lessons from the Covid-19 crisistowards centralizing policies for medical countermeasures to infectious diseases. One such hesitation could be the democratic basis of centralized EU decision making in making distributive choices with regard to medicines. However, at Member State level it is likely that such distributive choices -which require difficult scientific and ethical choices -are also a matter for the executive. The national parliament has the possibility to hold the executive to account after the choice has already be made, given the speed of decision making that the pandemic might require. When it comes to centralizing policies in response to infectious diseases, there is accountability to the national parliaments for the delegation decision and to the European Parliament and the national parliaments for the specific design of the policy. When it comes to the actual execution of the policy in the face of an urgency, accountability to the European Parliament can only be exerted ex post. The situation may be seen as analogous to Eurozone monetary policy, in which decisions are made by "technocratic experts", while the President of the ECB appears regularly for hearings in the European Parliament.